Pharmaceutical Serialization Playbook

Download this free e-book, updated for 2015 with the latest serialization success strategies.

With the passage of the Drug Quality and Security Act of 2013 (DQSA), everything you thought you knew about serialization has changed. Is your company ready? Download this free e-book, updated for 2015, with the latest serialization success strategies, real-world implementation tips, and pitfalls to avoid.

A detailed timeline lets you know what’s changing, and how soon. Easy-to-comprehend segments cover everything from assembling your serialization team, to pilot testing and more. Written for the entire serialization team, from packaging through IT, this Playbook is jam-packed with hands-on, actionable advice from those who’ve been there.

Experts

Sourced in this e-book

Bill Fletcher

Managing Partner

Pharma Logic Solutions

Dirk Rodgers

President

RxTrace

Robert Celeste

Director, Healthcare

GS1 US

Sean Mulholland

Senior Quality Compliance Officer

Almac Pharma Services

Greg Cathcart

CEO

Excellis Health Solutions

Dave Mason

Packaging Engineering Consultant

Neville Noel

Managing Partner

Endeavor Consulting Group

Stephen McIndoe

Vice President, Consulting

Be4ward

Jim John

Project Management Quality Consultant

ProPharma Group

Elliot Abreu

Senior Vice President

Xyntek-Antares

Jean-Pierre Allard

Serialization Product Manager

Optel Vision

Topics covered

The new U.S. law

Drug Quality and Security Act of 2013

Key concepts of the U.S. federal law

The timing of the U.S. federal law

Serialization around the world

Global compliance: Flexibility is the key

Staffing & project management

Building a proper serialization team

Secrets to serialization project management

11 steps to get started with serialization

11 routinely underestimated aspects of serialization

Line and plant strategies

Packaging line modifications for serialization

What “inference” is and why it matters

Strategies for accurate aggregation

Nine coding/marking considerations for serialization

Vision system considerations

Label and panel redesign considerations

Impact on production line speeds and OEE

Impact on production/operations workflows

The supply chain: Beyond the four walls

Transaction models and the U.S. drug supply chain

Transaction implications of the four views

Minimizing the complexity of connections

Impact on wholesaler/distributors, pharmacies, clinics, and hospitals

Contract manufacturing & packaging strategic considerations

Five implementation tips for CMO/CPO’s

Questions to ask your CMO/CPO about serialization

Software & Architecture

Line and plant level software implications

Avoid these EPCIS interoperability pitfalls

Issues with master data

How to avoid the leading zero issue

Preventing counterfeit transaction data

Pilot testing guide

Determining goals and metrics for pilot testing

Getting started with pilot testing

Pre-flighting your supply chain pilot

Lessons learned: project and vendor management

Lessons learned: on the packaging line

New GS1 help with pilots

Mixing serialized with non-serialized shipments

Downloads

Downloadable Word document with actual language to help you get started with your project:

Sample user requirements starter document

Plus: Vendor Selection Resource Guide

Questions to ask serialization solution providers

Detailed profiles of vendors who can help implement your serialization program

Praise from early reviewers for Healthcare Packaging’s Pharmaceutical Serialization Playbook:

"You did a great job capturing the essence of what people need to know."

"I just wanted to pause to tell you that you have created an incredibly useful and usable document that will help people come up to speed quickly and avoid the same mistakes that the pioneers made."

"Very well written."

"I’ve read through the playbook and everything looks great. Great work by you and your team."

"I think this is going to be an amazing source of information for the pharma industry. Great job!"

"Great information and I know we will be using this as a guideline to a successful serialization implementation. I sent this playbook to some team members and they thought this was "EXCELLENT" and a "WELL DONE DOCUMENT"! Hope others see the value as we do. Thanks for all your efforts and keeping me in the know."

"The playbook is excellent. I’d imagine this will serve as a critical document for the industry."

"I am pleased with the content of the playbook. Your team did an excellent job putting this content together."